August 6, 2020: India’s Zydus Cadila on Wednesday said that it has completed its COVID-19 vaccine’s first phase of human trial. 
It stated that its COVID-19 vaccine candidate was found to be safe and well-tolerated in an early-stage human trial. It will start phase 2 clinical trials to establish the efficacy of its anti-coronavirus disease (COVID-19) vaccine candidate from Thursday, the company said.
“The phase I dosing to establish the safety of ZyCoV-D is an important milestone,” Zydus Cadila Chairman Pankaj R Patel said. “All the subjects in phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post dosing for safety and for 7 days thereafter and the vaccine was found to be very safe. We now begin the phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population,” he added.
Earlier, the company had said that ZyCoV-D was found to be safe, immunogenic and well-tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit a high level of neutralizing antibodies in animal studies.
The company will now start a mid-stage trial of the vaccine candidate, ZyCoV-D, in over 1,000 healthy adult volunteers from Thursday to test its effectiveness, it said in a regulatory filing.
Zydus is also among the several Indian generic drugmakers that have licensing agreements with US-based Gilead Sciences to produce remdesivir, the antiviral that has been approved in the country as an emergency treatment to fight the coronavirus outbreak.
STORY HIGHLIGHTS
August 6, 2020: India’s Zydus Cadila on Wednesday said that it has completed its COVID-19 vaccine’s first phase of human trial.
August 6, 2020: India’s Zydus Cadila on Wednesday said that it has completed its COVID-19 vaccine’s first phase of human trial.
It stated that its COVID-19 vaccine candidate was found to be safe and well-tolerated in an early-stage human trial. It will start phase 2 clinical trials to establish the efficacy of its anti-coronavirus disease (COVID-19) vaccine candidate from Thursday, the company said.
“The phase I dosing to establish the safety of ZyCoV-D is an important milestone,” Zydus Cadila Chairman Pankaj R Patel said. “All the subjects in phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post dosing for safety and for 7 days thereafter and the vaccine was found to be very safe. We now begin the phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population,” he added.
Earlier, the company had said that ZyCoV-D was found to be safe, immunogenic and well-tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit a high level of neutralizing antibodies in animal studies.
The company will now start a mid-stage trial of the vaccine candidate, ZyCoV-D, in over 1,000 healthy adult volunteers from Thursday to test its effectiveness, it said in a regulatory filing.
Zydus is also among the several Indian generic drugmakers that have licensing agreements with US-based Gilead Sciences to produce remdesivir, the antiviral that has been approved in the country as an emergency treatment to fight the coronavirus outbreak.